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NCT01537029 · ClinicalTrials.gov registry record · Phase 4
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
A Phase 4 study, sponsored by Texas Tech University Health Sciences Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01537029: Completed Phase 4 study, sponsored by Texas Tech University Health Sciences Center.
NCT01537029 is a Phase 4 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537029, a Phase 4 study, has completed, sponsored by Texas Tech University Health Sciences Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.
Primary Outcome
Cyclophosphamide analysis was not possible due to rapid drug degradation
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT01537029 record still lists
NCT01537029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01537029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537029 about?
NCT01537029 is a clinical study titled "Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide". To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh mo...
What is the current status of trial NCT01537029?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2012-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01537029?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT01537029?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537029's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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